Covidien Says Device Linked to Three Deaths in Thoracic Surgery
Published: Jan 17, 2012
"After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures," said Bryan Hanson, Group President, Surgical Solutions, Covidien. "Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery."
Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. The Company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.
The affected product codes and descriptions are as follows:
DUET4535(TM) DUET TRS(TM) 45 3.5MM STRAIGHT SULU
DUET4535A(TM) DUET TRS(TM) 45 3.5MM ARTICULATING SULU
DUET4548(TM) DUET TRS(TM) 45 4.8MM STRAIGHT SULU
DUET4548A(TM) DUET TRS(TM) 45 4.8MM ARTICULATING SULU
DUET6035(TM) DUET TRS(TM) 60 3.5MM STRAIGHT SULU
DUET6035A(TM) DUET TRS(TM) 60 3.5MM ARTICULATING SULU
DUET6048(TM) DUET TRS(TM) 60 4.8MM STRAIGHT SULU
DUET6048A(TM) DUET TRS(TM) 60 4.8MM ARTICULATING SULU
Covidien is working with the United States Food and Drug Administration (FDA) and other worldwide regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Further, the Company placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use. Additionally, it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.
"These steps are consistent with our belief that patient safety is a commitment that cannot be compromised," said Hanson. "Patient safety is our first obligation."
Launched in 2009, the Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 500,000 units worldwide. Covidien believes approximately one-third of global procedures using Duet TRS are for thoracic indications. The Duet TRS will continue to be used for other indications, including abdominal procedures.
Customers have been notified of this recall by letter on January 12, 2012. Product intended for thoracic use must be returned. Please return the affected product by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Alternatively, customers may choose to retain the product for uses other than thoracic.
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.
-- Online: www.fda.gov/medwatch/report.htm
-- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm . Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-- Fax: 1-800-332-0178
-- Phone: 1-800-332-1088
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
Vice President, Communications & Public Affairs
Senior Vice President
Coleman Lannum, CFA